Cleared Traditional

Revolution Vibe

K250941 · Ge Medical Systems, LLC · Radiology
Aug 2025
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K250941 is an FDA 510(k) clearance for the Revolution Vibe, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on August 1, 2025, 126 days after receiving the submission on March 28, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K250941 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2025
Decision Date August 01, 2025
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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